The Effects of the Parents' Voice to Reduce the Heel Puncture Pain in High-Risk Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-02-23

Brief Summary

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High-risk neonates are forced to be separated from their parents due to hospitalization, and clinical medical treatment often causes pain and physical stress in high-risk newborns. Many literatures have confirmed that the mother's voice is positively helpful to the physiology of high-risk newborns, but few studies have been conducted on the father's voice. However, the parenting process is not only a link between the mother-child relationship, but also the impact of parental voice on high-risk newborns infants. Parent roles are expecting. The purpose of this study is to explore the effectiveness of parental voice intervention in high-risk newborns' heel puncture in reducing pain, and to further compare the mother and father's voice characteristics to the analysis of the pain degree of high-risk newborns.

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Detailed Description

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This study is a kind of experimental research design. The subjects are 105 infants with gestational weeks of more than 32 weeks. Randomly allocated are divided into one group of 35 in control group and 35 in each experimental group. On the third day after the birth of the high-risk newborns infant, the heel puncture times is lasted three minutes before the heel puncture to ten minutes after the puncture. The control groups only received general routine care, while the two parental experimental groups received the intervention that recording of parents voice of reading children's book. In the three groups, the pain of high-risk newborns was measured with the Heartbeat, Respiration and Neonatal Infant Pain Scale (NIPS) in three minutes before the heel puncture, during the puncture, and the first, fifth and tenth minutes after the puncture. It is hoped that the results of this study can help high-risk newborns to reduce pain with non-drug measures, and understand the influence of different voice characteristics on the development of infants, so as to provide future care personnel assisting parental role expectation and reference of clinical care.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mother's voice

Neonates receive the intervention that recording of mother's voice of reading children's book. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 and Neonatal Infant Pain Scale (NIPS) in three minutes before the heel puncture, during the puncture, and the first, fifth and tenth minutes after the puncture.

Group Type EXPERIMENTAL

Parents' Voice

Intervention Type BEHAVIORAL

the intervention is recording of parents voice of reading children's book.

Father's voice

Neonates receive the intervention that recording of father's voice of reading children's book. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 and Neonatal Infant Pain Scale (NIPS) in three minutes before the heel puncture, during the puncture, and the first, fifth and tenth minutes after the puncture.

Group Type EXPERIMENTAL

Parents' Voice

Intervention Type BEHAVIORAL

the intervention is recording of parents voice of reading children's book.

control group

When the infants undergoing heel puncture procedure, the control group were under routine care. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 and Neonatal Infant Pain Scale (NIPS) in three minutes before the heel puncture, during the puncture, and the first, fifth and tenth minutes after the puncture.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parents' Voice

the intervention is recording of parents voice of reading children's book.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* High-risk newborns over 32 weeks of age.
* Those who want to receive blood film collection for newborn screening on the third day of birth.
* The incubator is used for care during the hospitalization.
* The mother or father of the research subject can participate in the test all the way.
* After explaining and reading the consent form, the parents of the research subjects agree to participate in the research and obtain written consent.

Exclusion Criteria

* Apgar Score is still below 7 in the fifth minute.
* Being treated with a high-frequency positive pressure respirator.
* Suffering from congenital diseases including: ear canal malformation, cerebral palsy, Down's syndrome, congenital cyanotic heart disease.
* After the doctor's assessment, the patient should continue fasting due to the condition or restrict breastfeeding on demand.
* Instability of blood glucose after birth requires close monitoring of blood glucose, and has received more than three (including) heel puncture experiences.
* Birth injuries of the body due to the birth process, such as broken fetal head and broken collarbone.
* Are receiving medical treatment with sedatives.

Minimum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No